Torrent Pharma Inc. recalls Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT P
Recalled September 26, 2018 · FDA recall D-1204-2018 · Torrent Pharma
Hazard
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing. · FDA Class II
Units
15,384 30-count bottles
Sold at
Nationwide USA
Description
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Product
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30
Manufacturer(s)
Torrent Pharma Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →